A new FDA-approved syringe filled with algae- and fungi-based gel stops severe bleeding in seconds

A health professional wearing purple gloves holds up a syringe filled with a tan substance

As modern medicine evolves, the issue of severe bleeding is still enormously life-threatening, leaving first responders to use long-established methods like applying pressure, administering powder, using a tourniquet, or packing wounds with gauze. 

It’s clear — especially in severe situations where a patient has suffered a gunshot wound or deep cuts — that innovative alternatives could change the game. 

Fortunately, the U.S. Food and Drug Administration has just approved the use of a medical device called Traumagel, which is shown to stop severe bleeding in seconds.

The device is a 30-milliliter syringe filled with an algae- and fungi-based hemostatic gel (which has the color and texture of hummus, according to Fast Company). 

A syringe filled with a yellowy substance sits in front of a Traumagel package
Photo courtesy of Cresilon

Applying the solution directly into a wound, first responders can control bleeding within seconds.

“The ability to rapidly stop bleeding at the point of care and halt a life-threatening hemorrhage can be the difference between life and death for people with traumatic injuries,” said Joe Landolina, CEO and co-founder of the device’s manufacturing company, Cresilon.

According to a press release from Cresilon, 40% of gunshot or massive injury deaths are due to major hemorrhaging or its consequences. 

“The FDA clearance for TRAUMAGEL is a monumental milestone for Cresilon and brings us another step forward in our mission to save lives and transform the standard of care in emergency medicine,” Landolina added. “Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.”

Prior to the debut of this 30-milliliter syringe, the company created a similar Hemostatic Gel, which is a 5-ml version of the same product, designed to be used on minor cuts.

And before that, the technology was first employed in veterinary medicine, in a product named Vetigel. Vetigel has been utilized in procedures like spinal surgeries and teeth cleanings in over 10,000 veterinarian clinics, which allowed the company to scale to human-grade use.

A syringe filled with a tan substance next to a package for Vetigel Hemostatic Gel
Photo courtesy of Cresilon

“All of the work we’ve done to this point has not only allowed us to save lives in the pet space,” Landolina told Fast Company. “It’s also allowed us to build up the business functions that we need as we launch Traumagel.”

A major rollout of Traumagel is slated for later this year, as Cresilon markets the product for a variety of groups, including government health agencies, emergency medical services, medical professionals who treat traumatic wounds, and even the U.S. military.

Cresilon is currently working on a cooperative research and development agreement with the U.S. Defense Department’s Walter Reed Army Institute of Research to study the mitigation of life-threatening brain hemorrhages, as well. 

“91% of battlefield mortality is due to preventable hemorrhage,” Landolina told Fast Company, “Which means if there were only a better product to stop bleeding, lives could be saved.” 

Traumagel is a “better product” compared to gauze and tourniquets because it does not require pressure to work, meaning its impact is rendered in seconds, compared to treatment methods that can take several minutes to work.

“While several hemostatic agents and gauze bandages are currently available for applications such as trauma and surgery, many products require preparation and lengthy application time, can be difficult to apply, or are not suited to work across all types of bleeds,” Cresilon’s press release said.

“Cresilon’s plant-based hemostatic gel is supplied in a pre-filled syringe, easy-to-apply, requires no preparation, and designed to stop bleeding quickly across all types of bleeds.”

A young white man with brown hair smiles, wearing a gray quarter-zip sweater with the Vetigel logo on his chest
Joe Landolina. Photo courtesy of Cresilon

Moving forward, the company is focused on the launch of Traumagel, as well as training EMTs and physicians in the use of the product. 

In a Forbes article about Traumagel, Landolina did not specify the exact price of Traumagel, but said that it would be priced “competitively” to other treatments on the market, adding that it has to be accessible “in order to save lives.”

Header image courtesy of Cresilon

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August 16, 2024 10:23 AM
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